Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKelly McMasters
About this trial
The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.
Eligibility criteria
Qualifiers
Any patients with suspected (clinical) or definitive (tissue) diagnosis of Stage III-IV melanoma starting or continuing adjuvant Pembrolizumab without active evidence of disease (NED).
Must be treatment naïve or have had treatment no less than 6 months prior to enrollment
18 years or older
Must be able to take pills
Disqualifiers
History of hypersensitivity reactions attributed to beta-glucan
Patients receiving continuous or other ongoing immunosuppressive therapy
Uncontrolled intercurrent illness including, but not limited to, autoimmune diseases, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Any patients who have serious autoimmune toxicity during the study period, or those who have disease recurrence during the 6-week study period should be excluded and analyzed separately
Trial design
Treatments tested in this trial
- Beta-Glucan
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Kelly McMasters
Lead sponsor
University of Louisville
Sponsor institution
Source ClinicalTrials.gov